Assoc, QA - Batch Release

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1    To review executed Batch Manufacturing Records and Batch Packing Records. 
2    To ensure that every batch record is reviewed for its accuracy, completeness, and compliance with the established specifications to determine its disposition for release or reject.
3    To review all batch records and data against the requirements of applicable Technical Package, SOPs, specifications, Good Documentation Practices (GDPs), Good Manufacturing Practices (GMPs) and any impact on product quality, strength, identity, safety, purity, and quality prior to batch disposition.
4    To comply abnormality observed during Batch records review in coordination with respective functions.   
5    To ensure that all investigations associated with a batch records review has been completed, adequately investigated, and closed out prior to the batch disposition.
6    To prepare Batch Release Note once the batch comply with pre-defined specifications limits and marketing authorization requirement and prepare Batch Rejection note if it’s not complying.
7    If a non-conforming batch has been determined to be rejected, assure appropriate batch labelling has been applied and the batch is moved to the designated area of the warehouse.
8    To ensure current Good Manufacturing Practice (cGMP) standards are followed. 
9    To issue and generate rejected label for the rejected batch. 
10    To verify reject label audit trail report periodically as per define process. If any discrepancy found inform to Supervisor.    
11    To prepare change control management (CCM) or document change request (DCR) for Batch Release related activity.
12    To raise Non-conformance Report (NCR) if any non-compliance occurred during execution of Batch Release related activity.  
13    To prepare, review or revise SOPs at regular interval to meet regulatory requirement or complies internal audit observation (if any). 
14    To prepare Certificate of Conformity and Certificate of Manufacturing as per the PAC/partner requirement and submit to them.
15    To coordinate with PAC team for QP related query support as per procedure describe in standard operating procedure.
16    To support cross-functional staff for any Batch records related query resolution.
17    To initiate and implement appropriate corrective and preventive action in coordination with the respective function.
18    To perform execution task for Corrective Action and Preventive Action as well as for Change Control Management.
19    To submit Batch Release documents to IRA as per requirement and keep supervisor informed for the submission status.
20    To provide entry access to QA-office and retain sample room and maintain its document. 
21    To ensure the sample/batch destruction authorization procedure is performed when required.
22    To prepare time-to-time budget for purchase, purchase order and good receipt note for all the requirements related to batch release activities.
23    To communicate about any failure or abnormality notification to Supervisor & QA Head for their attention and seeking for the solution.
24    To keep status update of the released/rejected batches and report to Supervisor and QA Head on daily basis.
25    To seek area of improvement from QA Head and prepare implement action plan.

Reasonable Accommodations

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